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Pharma regulatory affairs
Pharma regulatory affairs
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CTD and eCTD

  1. 1. CTD and eCTD Girish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. g y p +91-9881492626 pr.girish@gmail.com
  2. 2. What is CTD/eCTD ? Common Technical Document (CTD): Its an format set by ICH which was agreed by the Regulatory Agencies of Europe, Japan & the US. Its electronic version called as electronic Common Technical Document (eCTD). Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 2 of 20
  3. 3. The CTD Triangle Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 3 of 20
  4. 4. CTD Modules Module 1 – Administrative Information (Region Specific) Module 2 – CTD Summaries (QOS) Module 3 – Quality (CMC) Module 4 – Non-Clinical Study Reports y p Module 5 – Clinical Study Reports Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 4 of 20
  5. 5. Module 1 Administrative Information (Region Specific) Should contain documents specific to each region For USA For EU Application form 356h Application form Proposed l b l d label Summary of product characteristics Patent certification / Labelling text and mock-ups information Information about the experts Debarment certificate Environmental risk assessment Letter of Authorization (LoA)/ DMF letter Description of the pharmacovigilance system Labeling text Risk management plan Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 5 of 20
  6. 6. Module 2 odu e CTD Summaries (QOS) It contain 7 sections in the following order: 2.1 CTD TOC (Module 2-5) 2.2 2 2 CTD Introduction 2.3 Quality Overall Summary 2.4 Non-clinical 2 4 Non clinical Overview 2.5 Clinical Overview 2.6 Non-Clinical 2 6 Non Clinical Summary 2.7 Clinical Summary Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 6 of 20
  7. 7. Module 3 Quality (CMC) 3.1 3 1 TOC of M d l 3 f Module 3.2 Body of Data 3.2.S - Drug substance 3.2.P - Drug product 3.2.A - Appendices d 3.2.R - Regional Information 3.3 3 3 Literature references f Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 7 of 20
  8. 8. Module 4 Non-Clinical Study Reports 4.1 4 1 TOC of M d l 4 f Module 4.2 Study reports 4.2.1 Pharmacology 4.2.2 Pharmacokinetics 4.2.3 Toxicology l 4.3 Literature References Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 8 of 20
  9. 9. Module 5 Clinical Study Reports 5.1 5 1 TOC of Module 5 5.2 Tabular listing of Clinical Studies 5.3 Clinical study reports 5.3.1 Reports of Biopharmaceutical (BA-BE) Study 5.3.2 Reports of Pharmacokinetic (biomaterial) study 5.3.3 Reports of Pharmacokinetic (PK) Studies 5.3.4 Reports of Pharmacodynamic (PD) Studies 5.3.5 Reports of Efficacy and Safety studies 5.3.6 Reports of Post-Marketing experience p g p 5.3.7 Case Report Forms & Individual patient listings 5.4 Literature References Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 9 of 20
  10. 10. eCTD Its electronic version of CTD so called as CTD, electronic Common Technical Document (eCTD). eCTD composed of two types of specification Content specification – As defined by ICH p y Technical specification – Electronic software's Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 10 of 20
  11. 11. eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs and INDs filing From year 2010 European Union also make y p compulsory for electronic CTD submission to all procedures Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 11 of 20
  12. 12. eCTD Characteristics Structure All Modules 1 to 5 have granularity options. PDF documents linked via XML backbone Increased document granularity granularity. Transparency of entire submission Ease of navigation and review Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 12 of 20
  13. 13. eCTD Template Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 13 of 20
  14. 14. M1 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 14 of 20
  15. 15. M2 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 15 of 20
  16. 16. M3 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 16 of 20
  17. 17. M4 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 17 of 20
  18. 18. M5 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 18 of 20
  19. 19. Benefits of eCTD Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 20
  20. 20. Thank Th k you Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 20 of 20

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